Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects - Full Text View

Purpose

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABT-267 in combination with Peginterferon alpha-2a/Ribavirin (pegIFN/RBV) for 12 weeks in treatment naïve Hepatitis C virus (HCV) genotype 1 infected subjects.

Condition	Intervention	Phase
Chronic Hepatitis C Hepatitis C Virus (HCV)	Drug: ABT-267 Drug: Peginterferon alpha-2a (pegIFN) Drug: Ribavirin (RBV) Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Assess 4-week rapid virologic response (RVR) [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
Assess 4-week rapid virologic response (RVR) of three different doses of ABT-267 in combination with pegIFN/RBV compared to pegIFN/RBV alone (ABT-267 placebo) in HCV genotype 1-infected treatment-naive adults.

Secondary Outcome Measures:

Assess percentage of subjects with partial early virologic response (EVR). [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Assess the percentage of subjects with partial virologic response (EVR).
Assess percentage of subjects with complete early virologic response (cEVR). [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Assess percentage of subjects with complete early virologic response (cEVR).

Enrollment:	37
Study Start Date:	March 2011
Study Completion Date:	February 2013
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Low dose ABT-267 + Peginterferon alpha-2a/Ribavirin (pegIFN/RBV)	Drug: ABT-267 tablet Drug: Peginterferon alpha-2a (pegIFN) injectible solution Drug: Ribavirin (RBV) tablet
Experimental: Arm 2 Medium dose ABT-267 + pegIFN/RBV	Drug: ABT-267 tablet Drug: Peginterferon alpha-2a (pegIFN) injectible solution Drug: Ribavirin (RBV) tablet
Experimental: Arm 3 High dose ABT-267 + pegIFN/RBV	Drug: ABT-267 tablet Drug: Peginterferon alpha-2a (pegIFN) injectible solution Drug: Ribavirin (RBV) tablet
Placebo Comparator: Arm 4 Placebo + pegIFN/RBV	Drug: Peginterferon alpha-2a (pegIFN) injectible solution Drug: Ribavirin (RBV) tablet Drug: Placebo tablet

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, 18-65 years old, inclusive.
Treatment naïve.
Females must be either postmenopausal for at least 2 years or surgically sterile and males must be surgically sterile or practicing specific forms of birth control.
Chronic hepatitis C virus (HCV) genotype-1 infection.
Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis.

Exclusion Criteria:

Pregnant or breastfeeding female.
Use of any medications contraindicated for use with Peginterferon alpha-2a (pegIFN) or Ribavirin (RBV) within 2 weeks prior to study drug administration.
Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, or neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder.
Current or past clinical evidence of cirrhosis or bridging fibrosis.
Abnormal screening laboratory results.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314261

Locations

United States, Alabama
Site Reference ID/Investigator# 56623
Birmingham, Alabama, United States, 35215
United States, California
Site Reference ID/Investigator# 48476
Los Angeles, California, United States, 90048
United States, Florida
Site Reference ID/Investigator# 51345
Orlando, Florida, United States, 32809
United States, Hawaii
Site Reference ID/Investigator# 51498
Honolulu, Hawaii, United States, 96814
United States, Indiana
Site Reference ID/Investigator# 48473
Indianapolis, Indiana, United States, 46202
United States, Missouri
Site Reference ID/Investigator# 52782
Kansas City, Missouri, United States, 64134
United States, Texas
Site Reference ID/Investigator# 48471
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 48474
San Antonio, Texas, United States, 78215
United States, Virginia
Site Reference ID/Investigator# 48477
Fairfax, Virginia, United States, 22031
United States, Washington
Site Reference ID/Investigator# 48472
Seattle, Washington, United States, 98101
Puerto Rico
Site Reference ID/Investigator# 48483
San Juan, Puerto Rico, 00927

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Armen Asatryan, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01314261 History of Changes
Other Study ID Numbers:	M12-114
Study First Received:	March 11, 2011
Last Updated:	March 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013